Sierra offers Autoclave Validation Services with the Kaye Validator 2000, a standalone thermal validation solution specifically designed to conform with FDA data protection guidelines (21 CFR Part 11) and meet international and European cGMP requirements for inspection of pharmaceutical, biotechnology and medical device (EN285, EN554) manufacturing.
The Validator 2000 simplifies the entire validation process by reducing setup time and minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports.
• Meets FDA guidelines for protecting electronic data (21 CFR Part 11)
• Prevents unauthorized access via user ID and password for critical operations
• Creates secure results using files that cannot be used if tampered with
• Creates printed or spreadsheet reports from a single protected file.
• Creates comprehensive audit trail of all actions affecting user data.
• Supplied power cable and SIM's
We are pleased to offer a Comprehensive Scope of Qualification & Validation for Pharmaceutical Equipment's such as Autoclaves & Sterilizers, Depyrogenation Ovens, Freezers, Incubators, Lyophilizers, Refrigerators, Shipper Studies & Routes, Stability Chambers, Steam-in-Place, Environmental Monitoring Systems, Room Mapping, Warehouses & more.
We use World Class Validation equipment from GE-KAYE-Amphenol with high accurate Temperature Sensors, Automated Validation Reports, 21Cfr Part11 compliant Reports with Audit Trails that builds confidence in Validation. We are pleased to introduce a brief profile of Sierra Validation Services for your immediate reference:
Kaye Validation Services:
Sierra your trusted partner for qualification excellence: Sierra's qualification and validation testing provides documented evidence that equipment is installed correctly, operates accurately, and performs reliably. The Sierra validation team executes validation projects throughout the country and abroad which contributes to their diverse experience. For over 24 years Sierra has validated hundreds of environmental chambers and other laboratory equipment of all makes models, capacities, and conditions. Sierra has developed a broad and deep portfolio of equipment validation capabilities. We have the experience to solve your validation problems.
• Sierra offers comprehensive qualification services: Sierra validation services group qualifies your laboratory equipment and environmental storage spaces, ensuring your equipment performs accurately and reliably.
• Correct Qualification Protocol for Your Specific Requirements: Sierra performs precise qualification based on your approved standard operating procedures (SOPs). We can follow your Installation, Operational, and Performance Qualification (IQ / OQ / PQ) protocols.
Pre-Calibration to Improve Efficiency and Cost-Effectiveness: As a cost-saving measure we use Stable & Accurate temperature Bath to perform pre-calibration of all Validation sensors before performing equipment qualification. We apply our experience with instrumentation and controls to bring your equipment into compliance. Through pre-calibration efforts, we provide a level of confidence on the outcome (pass or fail) of equipment validation helping you make the best decision before you spend time and money on further testing.
• Post-Calibration Verification to confirm accuracy: All certified validation and calibration equipment used at customer sites is verified onsite using high accuracy & stable temperature bath by performing post-calibration verification. This completes the physical execution of the qualification that was performed at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable, and repeatable.
• Quick Delivery of a Quality-Checked Documentation Package: At the conclusion of equipment validation, Sierra will provide a clear, comprehensive validation report, confirming that your equipment is fit for use for your requirements. Our validation reports contain all the necessary data for you to have confidence in your equipment. Each report is independently reviewed by a credentialed quality professional, saving you time and money.
• Fast Turnaround Time Keeps Your Operations on-Schedule: Sierra understands that any equipment out of service can negatively impact your scheduling and capacity. With our fully-staffed in-house validation team and the largest fleet of validation equipment available, we can confidently meet or exceed your time frame requirements without sacrificing quality or accuracy. Sierra’s skilled professionals can perform multiple qualifications simultaneously using multiple data logging systems, keeping your schedule on track.
Our Commitment : Accurate Validation Equipment’s, meticulous documentation, 24+ years’ experience & commitment on Quality standards exceeding your expectations.